MedImmune's Biopharmaceutical Development (BPD) develops the process and analytics to produce and characterize product candidates, including the formulations and drug product formats, for delivering medicines to patients. The regulated aspect of this work is known as the Chemistry, Manufacture, and Control (CMC) part of product development. MedImmune conducts BPD at our facilities in Gaithersburg, MD; Mountain View/Santa Clara, CA; and Cambridge, UK.
With a strong focus on science and technology, BPD is accountable for product development, CMC strategy, and delivery. Activity starts in the research phase. Working closely with the research, BPD helps define and select the best project candidates to progress into development. As a product candidate enters the development phase, our BPD scientists are responsible for:
- Cell line, analytical, process, and formulation/delivery development. We have established a competitive high titer antibody platform, with routine productivities that exceed 5-10 g/L in cell culture and purification operations with capacity and flexibility to fit high titer processes efficiently into a manufacturing plant. This platform allows for lower cost of goods, manufacturing flexibility, and shorter development cycle time for antibody products.
- Development activities are supported by state-of-the-art analytical sciences.
- Products are developed using a wide range of progressive formulation and drug delivery technologies to ensure effectiveness and commercial success.
- Manufacture of clinical supplies for all phases of clinical trials. We manufacture material for clinical trials according to strict industry standards known as good manufacturing practices (GMPs). The majority of GMP material is made in the Gaithersburg Pilot Facility (GPF), which produces the drug substance, and the Operations site in Nijmegen, Netherlands, where it is filled into vials. BPD also supports the manufacture of clinical trial material by Contract Manufacture Organizations (CMOs) where required.
- Transfer of product and process knowledge to commercial manufacturing. Transfer and manufacturing is primarily focused on our state-of-the-art commercial manufacturing facility in Frederick, MD, and our Operations site in Nijmegen, Netherlands where the drug product is filled into vials.
- Lifetime support for biologic products. BPD provides continual scientific support for our products after they leave the Research and Development (R&D) phase and enter the market. This ensures that the commercial products we manufacture are supported by the highest scientific standards and meet evolving technical regulatory requirements.
BPD’s core capabilities are anchored and built around scientific expertise in process cell culture, process biochemistry, bioprocess engineering, manufacturing sciences, analytical biochemistry, formulation sciences, drug product manufacturing, devices, and drug delivery. These core capabilities are tightly aligned to our pipeline requirements and business strategy, and allow us to deliver important medicines to patients.
BPD continues to build capabilities to meet the needs of our future R&D portfolio, including:
- Investing in process, analytical, formulation, and drug delivery technologies to meet the development needs of the exciting and innovative drug candidates in MedImmune’s pipeline.
- Extending our strong internal science base with an array of collaborations with leading academic groups and technology companies around the globe. This includes a substantial effort to present our work in scientific journals and conferences worldwide.
- Working closely with other departments in MedImmune, including Research, Regulatory Affairs, Clinical Development, Emerging Brands, and Operations, to ensure project needs are met and innovative medicines are made available to patients.
- Engaging regulators to ensure that our medicines can be provided to patients under the framework of the latest scientific and regulatory thinking – for example, participating in the Quality by Design (QbD) Pilot Program with the FDA.
- Working with MedImmune’s development partners to ensure the needs of projects we are co-developing are met.